cihov38610
Veteran Member
Posts: 1,275
Status: Offline
Joined:
pmwww
| | 510k submission (2nd Jan 26 at 3:44am UTC) | | | A 510(k) submission is a premarket filing to the U.S. FDA that demonstrates a medical device is substantially equivalent to an already legally marketed device (a predicate device). It includes details on the device’s design, materials, intended use, performance data, and safety testing. Once cleared, the manufacturer can market the device in the United States without needing full premarket approval (PMA). | |
Hello everyone! Welcome to my page! I am a project manager specializing in haccp certification course online. I am excited to share my experiences and learn from my fellow bloggers!
|
|
